Matt on Cediranib Phase 2 clinical Trial at NIH

[wendik]

Hello friends!

It seems we have finally returned from Bethesda with some better news. Although Matt is still getting a "mixed response", and the size of his tumors is still basically stable, the PET showed significant decrease in metabolic activity of the largest masses. It seems that his tumors are much less active.

This is the best report we have had so far. Although some of his lung nodules are a bit larger, The huge masses on his sacrum and in his glut are definitely responding to treatment. He is going to remain on the study for as long as he is stable.

Although Nathan's post was discouraging, thank heaven Matt is still not having as many side effects after 8 months as others are. He seems to tolerate the cediranib better than most. Time will tell, I suppose.

This hopeful news comes as Matt is preparing to move back home and return to work after 10 months off. It couldn't have come at a better time.

Wendy

[Fictional]

Congratulations, Wendy and Matt! This is wonderful news.

The PET signal may go down first and then you may see more tumor death.

The low / tolerable side effects are also great to hear.

Blessings, 'F'

[Bonni Hess]

Dear Wendy,
This is wonderful and very welcome and encouraging news, and I am so very happy for Matt and your family Hopefully once the Cediranib has been able to successfully shrink Matt's large tumors and reduce the tumor burden, it will be able to work better on stabilizing the growth of his lung mets. Eight months with no new tumors is certainly a great victory in itself with this insidious disease. I am grateful that Matt is tolerating the medication so well and is feeling good enough to now be able to return to work. Please share with him my special congratulations, very best wishes, and a happy hug, and keep in touch with this Board as you are able.Take care dear Wendy, enjoy the great relief and joy that this good news brings, and keep holding tight to Hope.
Sharing the happiness of your good news with special caring thoughs and continued Hope,
Bonni

[cachabamba10]

Dear Wendy:

I just read the news on Matt's visit to the NIH/NCI. This is good news, hopefully this gives you a small brake from stress and anxiety. You all take care and keep us updated.

Give my regards to Matt, take care Wendy.

Sincerely;

Mario E. Arevalo

[jcs2007]

Wendy,
Thanks for sharing the good news about Matt. I am glad he is tolerating the medicine and will
be able to move home and return to work. Thanks for the update.
Wishing you peace and blessings,
cindy

[wendik]

Matt and Larry are in Bethsda. Re-staging tomorrow.

Here comes that old "scanxiety" again.

Wendy

[Bonni Hess]

Dear Wendy,
I am right there with you in heart and thought, and holding VERY tight to Hope that Matt's today's scans will show continued stable disease and increased tumor shrinkage. I will be anxiously awaiting your Hopefully good news update when your time and the situation allow.
With warm hugs, deepest caring, healing wishes for Matt, and continued Hope,
Bonni

[wendik]

Hello everyone,

It is with a heavy heart that I am letting you all know that Matt has been taken off the Cediranib protocol. It seems that a small pinprick (missed) on the last scan in the LUQ of his abdomed is now a 2.2 cm subcutaneous lesion. They consider this as disease progression, therefore he is off. They also feel that his sacral lesion is enlarging, although it doesn't measure any larger the SUV increased from 4.6 to 6.4. (and has become increasingly more painful) They are using a new PET machine there, so I don't really know how they can do a proper comparison, but that is the decison they've come to.

Dr. Kummar and her team are just several weeks away from beginning a new trial of a combo of avastin and a topoisomerase inhibitor called SN-38. They want Matt to participate. It would involve infusions every two weeks. They have also alternatively suggested Sutent. Our local oncologist feels that both options are appropriate, although he is "mad as He--" at the beurocratic decision to take Matt off when his disease really is still basically stable.

Olga and 'F', can you guys check this new trial out for us? I do trust your judgement.

Meanwhile, now Matt is on NOTHING, and they are anticipating the new trial to begin in 4-5 weeks, which is about right as he has to be 28 days treatment-free. I am so scared at this point, I am just beside myself. If he were to start Sutent it would just be pending insurance approval. (many hoops to jump through).

Matt of course is angry and depressed, but we knew the rules when we got into this, and we try to keep telling ourselves that maybe there's something better for him out there.

Special thanks to Bonni and Arch for your kind words.....This board means the world to me and has literally been my ray of hope for the last year.

Wendy

[Olga]

Wendi, I think that Sunitinib is a good option to start now, because Matt was a responder to cediranib and has good chance to respond to sunitinib. But I would resect the subcutaneous met first - you will need a time for the insurance approval anyways, right? It looks like soft tissue mets are less responsive to TKI - the same case was with Brittany's abdomen soft tissue subcutaneous met. Her awesome oncologist from Alberta just led her to resect that one and to continue on the cediranib and her response continued further after that, may be you want to talk to NCI about that and appleal their decision based on that case, the contact info of the oncologist might be provided to them. That oncologist was under the different rules though as his trial is Phase 1 and he is only studying the tolerability of the drug not the efficacy, but the example that the rest of the mets were and are responding might say something to them.

[skyflower]

Hi Wendy,
I know how anxious you must be feeling, we are still forming a go-forward plan with lucio. Since there's a good month or so to gather your thoughts and research it's probably a good idea to take this opportunity to get second, third, fourth opinions (assuming insurance covers it of course!)
You might have missed all of the activity, but 'F' is no longer part of this forum, if you notice her name is grayed out and unclickable. All of the posts related to that have been erased so i'm not sure it's on record anywhere. She is very active with e-mail, I'm pretty sure it's ok to plug that because she has shared her personal e-mail on the board many times previously and it's probably floating around in one of her posts.
Is cryo or any other ablation an option for Matt's primary, or any concerning mets? Has he been evaluated post-cediranib to see if his mets are resectable? Lucio's turn-around time for getting Sutent through Aetna was about 7-10 days and didn't require an appeal. Along with the request, his primary oncologist sent in an article from up-to-date showing support for effectiveness of sutent in ASPS. Side effects so far are better tolerated than Cediranib, but he does have his moments. We have been getting opinions from radiologists as well, but mostly it's to humor his primary oncologist :/
we're thinking of Matt. we hope he is able to gain weight and strength in this downtime from coming off cediranib.

[Olga]

Wendy, I keep thinking about this growing met in the abdomen that was the reason that Matt is taken off the trial. I have this theory that the one that Brittany had resected (and it was also growing and non responsive to cediranib) was probably the result of one of the examination of her liver mets or other mets that were performed with the fine-needle aspiration, as a needle track dissemination and the reason it would not respond to the cediranib was that it wasn't connected to the systemic blood supply like the other mets that were disseminated by the blood stream, so the accumulation of the cediranib there was very low. What do you think, does Matts case look similar, they probably did take the FNA biopsy of his pelvic mets?

[wendik]

Olga,
No, the only Bx that Matt EVER had was of his right flank, which is one of the tumors that responded well to cediranib. Do you know anything about this bevacizumab/sn-38 trial??? Matt seems to be leaning strongly in that direction. He says the Sutent will be there for him if (when) this fails. His oncologists hate the idea of ANY resection, and they have him brainwashed against it. Matt is determined to stay at work, now that he's back there and surgery could change that, although I don't see how resecting this small sub-q tumor would cause too much of a problem. I'll will discuss it with his onc on tuesday at his appt.

Thanks for keeping us in your thoughts

Wendy

[wendik]

Oh, forgot to say that that Bx, about a year ago, was long before he entered cediranib therapy. It was an incisional bx, and it was the one that led to his diagnosis.

[Olga]

OK, so the subcutaneous met is not biopsy related, but still may be soft tissue mets are less responsive to the cediranib.
I really do not know what to say about the bevacizumab/sn-38 trial and I do not support Matts idea that sunitinib will be here avail for him when he needs it and because of that it might be postponed and that might be the rationale to pick the trial. We know that long lasting response to sunitinib is possible but there is no information that bevacizumab/sn-38 might be helpful so its like a wild shot - like any Phase 1 trials. If Matt goes to sunitinib and with some good luck stays on it for awhile, something new more promising can make its way to the Phase 2 trial and he might be able to have the more promising treatment then. Clinical trials of Phase 1 should be reserved for the people with no options and since there is a very legit sunitinib option, how would that choice be justified.

[Bonni Hess]

Dear Wendy and Olga,
I am sorry to be slow in responding, but we just returned from a week's vacation in Mexico. Regarding your theory Olga on Brittany's abdominal met being caused by needle track dissemination resulting from a fine needle aspiration biopsy of her liver met, Brittany has not had any biopsies since her initial biopsy of her primary tumor in her thigh nine+ years ago. We feel that biopsies just increase the risk of spreading the disease, and have always taken the approach of resecting or treating the met on the assumption that the met is most likely an ASPS met given the metastatic nature of this disease. However, I do agree, as does Dr. Sawyer, that Brittany's subcutaneous abdominal met did not respond to the Cediranib because it was not connected to the blood vessels.
Wendy, I am perplexed about Matt's oncologists strong opposition to resecting his tumors since ASPS studies have documented that resection is the best treatment approach for ASPS if it is surgically possible. Removal of the tumors helps to lessen the tumor burden, and enables the body and systemic treatments to better fight the disease. I am concerned that the reason that the Cediranib was ultimately unsuccessful in preventing disease progression for Matt is because he has too much tumor burden with his primary tumor, and that this might be a problem with any subsequent systemic treatments that he receives. What rationale do the oncologists offer for their opposition to resection? I agree with Olga regarding Matt's decision to probably pursue bevacizumab (also called Avastin) instead of Sutent. To my knowledge, Avastin has unfortunately thus far not been proven to be successful in treating ASPS, whereas Sutent has provided tumor shrinkage and disease stabilization for up to two years in some ASPS patients. I know that these are very difficult decisions to make, and no one knows for sure what the right answer is, but I encourage Matt and you to thoroughly research and discuss all of the treatment options with several different sarcoma specialists before moving forward with treatment. My continued most caring thoughts and best wishes are with Matt and your family, and I will be anxiously awaiting your next update. Take care dear friend.
With deepest caring, healing wishes for Matt, and continued Hope,
Bonni